Analgesic Efficacy And Safety of Valdecoxib For Treatment Of Post-Surgical Pain From Bunionectomy Surgery
Clinical Protocol for a Multiple Dose Randomized, Double-Blind, Placebo Controlled Study of the Analgesic Efficacy and Safety of Valdecoxib Compared to Placebo in Patients for Treatment of Post-Surgical Pain From Bunionectomy Surgery
2 other identifiers
interventional
450
1 country
89
Brief Summary
The study was done to evaluate the pain relief and safety of 2 valdecoxib doses compared to placebo in patients with moderate or severe pain following bunionectomy surgery, and to evaluate the effect of the 2 valdecoxib doses compared to placebo on health outcome measures and on the occurrence of opioid related symptoms.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 pain
Started Oct 2002
Shorter than P25 for phase_3 pain
89 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2003
CompletedFirst Submitted
Initial submission to the registry
March 31, 2008
CompletedFirst Posted
Study publicly available on registry
May 23, 2008
CompletedMay 23, 2008
May 1, 2008
March 31, 2008
May 22, 2008
Conditions
Outcome Measures
Primary Outcomes (2)
Patient's Global Evaluation of Study Medication
Day 2 and Day 3
Summed Pain Intensity (SPI) (categorical) through 24 hours
Day 2 and Day 3
Secondary Outcomes (15)
Health Outcomes Post-Discharge Recovery Experience
Days 2 to 5
adverse events
continuous
Time to first dose of rescue medication (rescue analgesic medication)
Days 2 to 5
SPI 24 (categorical)
Day 4 and Day 5
Time-specific Pain Intensity (PI) (categorical)
Days 2 to 5
- +10 more secondary outcomes
Study Arms (3)
Arm 1
ACTIVE COMPARATORArm 2
ACTIVE COMPARATORArm 3
ACTIVE COMPARATORInterventions
valdecoxib 40 mg tablet by mouth followed by a valdecoxib 20 mg tablet by mouth after 1 to 12 hours of the initial dose on Day 1 then a valdecoxib 20 mg tablet by mouth once daily on Days 2 through 5
valdecoxib 40 mg tablet by mouth followed by a valdecoxib 20 mg tablet by mouth after 1 to 12 hours of the initial dose on Day 1 then placebo on Days 2 through 5
Eligibility Criteria
You may qualify if:
- Patients who underwent an uncomplicated primary unilateral first metatarsal bunionectomy surgery (with or without ipsilateral hammer toe repair) who required open manipulation of bone with periosteal evaluation under general anesthesia (Mayo block)
- Patients with a baseline pain intensity (VAS) of greater than or equal to 45 mm
- Patients with a baseline pain intensity (categorical) of moderate or severe
You may not qualify if:
- Patients scheduled to undergo other surgical procedures that would be expected to produce a greater degree of surgical trauma than the orthopedic procedure alone
- Treatment with patient-controlled analgesia (PCA) subsequent to the end of anesthesia
- Long-acting local anesthetics or local anesthetics coadministered with epinephrine injected into the index joint space
- Use of tricyclic antidepressants, tranquilizers, neuroleptics, neuroleptic antiemetics, COX-2 inhibitors, NSAIDs, and corticosteroids
- Use of NSAID or analgesia after midnight the night prior to surgery or unwilling to abstain from NSAIDs or other analgesics, except as specified in the protocol, during the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (89)
Pfizer Investigational Site
Chandler, Arizona, 85224, United States
Pfizer Investigational Site
Glendale, Arizona, 85302, United States
Pfizer Investigational Site
Glendale, Arizona, 85306, United States
Pfizer Investigational Site
Mesa, Arizona, 85204, United States
Pfizer Investigational Site
Phoenix, Arizona, 58029, United States
Pfizer Investigational Site
Phoenix, Arizona, 85012, United States
Pfizer Investigational Site
Phoenix, Arizona, 85015, United States
Pfizer Investigational Site
Phoenix, Arizona, 85016, United States
Pfizer Investigational Site
Phoenix, Arizona, 85022, United States
Pfizer Investigational Site
Phoenix, Arizona, 85023, United States
Pfizer Investigational Site
National City, California, 91950, United States
Pfizer Investigational Site
San Diego, California, 91950, United States
Pfizer Investigational Site
San Diego, California, 92103, United States
Pfizer Investigational Site
San Diego, California, 92114, United States
Pfizer Investigational Site
San Diego, California, 92116, United States
Pfizer Investigational Site
Milford, Connecticut, 06460, United States
Pfizer Investigational Site
New Haven, Connecticut, 06515, United States
Pfizer Investigational Site
New Haven, Connecticut, 6515, United States
Pfizer Investigational Site
Cooper City, Florida, 33330, United States
Pfizer Investigational Site
Cutler Ridge, Florida, 33157, United States
Pfizer Investigational Site
Fort Lauderdale, Florida, 33306, United States
Pfizer Investigational Site
Fort Lauderdale, Florida, 33308, United States
Pfizer Investigational Site
Hallandale, Florida, 33009, United States
Pfizer Investigational Site
Hollywood, Florida, 33020, United States
Pfizer Investigational Site
Hollywood, Florida, 33021, United States
Pfizer Investigational Site
Miami, Florida, 33180, United States
Pfizer Investigational Site
New Port Richey, Florida, 34652, United States
Pfizer Investigational Site
New Port Richey, Florida, 34653, United States
Pfizer Investigational Site
New Port Richey, Florida, 34655, United States
Pfizer Investigational Site
Pembroke Pines, Florida, 33027, United States
Pfizer Investigational Site
Pembroke Pines, Florida, 33028, United States
Pfizer Investigational Site
Port Richey, Florida, 34668, United States
Pfizer Investigational Site
South Miami, Florida, 33143, United States
Pfizer Investigational Site
Spring Hill, Florida, 34608, United States
Pfizer Investigational Site
Addison, Illinois, 60101, United States
Pfizer Investigational Site
Elk Grove Village, Illinois, 60007, United States
Pfizer Investigational Site
Peoria, Illinois, 61602, United States
Pfizer Investigational Site
Peoria, Illinois, 61614, United States
Pfizer Investigational Site
Peoria, Illinois, 61615, United States
Pfizer Investigational Site
Evansville, Indiana, 47713, United States
Pfizer Investigational Site
New Orleans, Louisiana, 70127, United States
Pfizer Investigational Site
New Orleans, Louisiana, 70128, United States
Pfizer Investigational Site
Annapolis, Maryland, 21401, United States
Pfizer Investigational Site
Chester, Maryland, 21619, United States
Pfizer Investigational Site
Omaha, Nebraska, 68124, United States
Pfizer Investigational Site
Omaha, Nebraska, 68134, United States
Pfizer Investigational Site
Omaha, Nebraska, 68144, United States
Pfizer Investigational Site
Las Vegas, Nevada, 89102, United States
Pfizer Investigational Site
Las Vegas, Nevada, 89104, United States
Pfizer Investigational Site
Las Vegas, Nevada, 89106, United States
Pfizer Investigational Site
Las Vegas, Nevada, 89121, United States
Pfizer Investigational Site
Las Vegas, Nevada, 89128, United States
Pfizer Investigational Site
Bismarck, North Dakota, 58501, United States
Pfizer Investigational Site
Austintown, Ohio, 44515, United States
Pfizer Investigational Site
Canfield, Ohio, 44406, United States
Pfizer Investigational Site
Cleveland, Ohio, 44106, United States
Pfizer Investigational Site
Youngstown, Ohio, 44512, United States
Pfizer Investigational Site
Youngstown, Ohio, 44515, United States
Pfizer Investigational Site
Portland, Oregon, 97205, United States
Pfizer Investigational Site
Altoona, Pennsylvania, 16602, United States
Pfizer Investigational Site
Altoona, Pennsylvania, United States
Pfizer Investigational Site
Duncansville, Pennsylvania, 16635, United States
Pfizer Investigational Site
Havertown, Pennsylvania, 19083, United States
Pfizer Investigational Site
Media, Pennsylvania, 19063, United States
Pfizer Investigational Site
Philadelphia, Pennsylvania, 19107-2496, United States
Pfizer Investigational Site
Philadelphia, Pennsylvania, 19140, United States
Pfizer Investigational Site
Philadelphia, Pennsylvania, United States
Pfizer Investigational Site
Reading, Pennsylvania, 19606, United States
Pfizer Investigational Site
State College, Pennsylvania, 16803, United States
Pfizer Investigational Site
Upland, Pennsylvania, 19013, United States
Pfizer Investigational Site
Wyomissig, Pennsylvania, 19610, United States
Pfizer Investigational Site
Greer, South Carolina, 29651, United States
Pfizer Investigational Site
Austin, Texas, 78731, United States
Pfizer Investigational Site
Austin, Texas, 78756, United States
Pfizer Investigational Site
San Antonio, Texas, 78205, United States
Pfizer Investigational Site
San Antonio, Texas, 78209, United States
Pfizer Investigational Site
San Antonio, Texas, 78240, United States
Pfizer Investigational Site
San Antonio, Texas, United States
Pfizer Investigational Site
Holladay, Utah, 84117, United States
Pfizer Investigational Site
Layton, Utah, 84041, United States
Pfizer Investigational Site
Provo, Utah, 84054, United States
Pfizer Investigational Site
Salt Lake City, Utah, 84102, United States
Pfizer Investigational Site
Salt Lake City, Utah, 84107, United States
Pfizer Investigational Site
Salt Lake City, Utah, 84117, United States
Pfizer Investigational Site
Salt Lake City, Utah, 84124, United States
Pfizer Investigational Site
Salt Lake City, Utah, 84157-0667, United States
Pfizer Investigational Site
Sandy City, Utah, 84070, United States
Pfizer Investigational Site
St. George, Utah, 84770, United States
Pfizer Investigational Site
Tacoma, Washington, 98431-5000, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 31, 2008
First Posted
May 23, 2008
Study Start
October 1, 2002
Study Completion
February 1, 2003
Last Updated
May 23, 2008
Record last verified: 2008-05